AQT90 FLEX D-dimer Clinical Sensitivity and Specificity

NCT06749223 | Recruiting

• 1 other identifier: DC-078241
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is evaluate the clinical performance of the AQT90 FLEX D-dimer Test as an aid in the diagnosis of Venous Thromboembolism.

Conditions

VTE (Venous Thromboembolism)

Keywords

D-dimer

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity

  Clinical performance (clinical sensitivity, clinical specificity, Negative Predictive Values (NPV), Positive Predictive Values (PPV), Positive Likelihood Ratio (LR+), Negative Likelihood Ratio (LR-) and 95 % confidence intervals) for the AQT90 FLEX D-dimer assay against the hospital diagnosis.

  From enrollment to blood sample collection; ~1 hour

Interventions

D-dimer test DIAGNOSTIC_TEST

Blood sample collection for D-dimer testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients presenting with signs and symptoms of VTE and getting clinical evaluation of the pretest probability of VTE scored as low or moderate corresponding to a Well's score between 0-2 for DVT and between 0-6 for PE.

You may qualify if:

• Subject is 18 years of age and older
• Subject, who presents with signs and symptoms of VTE and had low or moderate pre-test probability of DVT or PE assessed by Well's score
• Subject must be able to understand information given, and be willing and able to voluntarily give their consent to participate in this study

You may not qualify if:

• Subject, who is pregnant
• Subject, who has received fibrinolytic therapy within the previous seven days
• Subject, who has received treatment with anticoagulants (unfractionated heparin, LMWH, VKA (vitamin K-antagonists), DOACs (direct oral anticoagulants) within the previous seven days
• Subject, who has had trauma or surgery within the previous four weeks
• Subject with malignancy
• Subject with disseminated intravascular coagulation (DIC)
• Subject, who has an invalid written informed consent or has withdrawn consent

Sponsors & Collaborators

• Radiometer Medical ApS: lead

Study Sites (1)

Viborg Regional Hospital

Viborg, 8800, Denmark

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Helle Toftegaard Petersen

CONTACT

+45 29259390; helle.toftegaard@radiometer.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: April 4, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)